关键词: Clinical trial protocol Health equity Implementation science Postpartum depression Pragmatic trials Prevention Scale-up

Mesh : Female Humans Infant, Newborn Pregnancy Cost-Benefit Analysis Depression, Postpartum / diagnosis prevention & control Mothers Preventive Health Services Research Design United States

来  源:   DOI:10.1016/j.cct.2023.107297   PDF(Pubmed)

Abstract:
To examine the effectiveness, cost-outcome, equity, scalability, and mechanisms of the Reach Out, Stay strong, Essentials for mothers of newborns (ROSE) postpartum depression prevention (PPD) program as universal versus selective or indicated prevention.
The United States Preventive Services Task Force (USPSTF) currently recommends PPD prevention for pregnant people at risk of PPD (i.e., selective/indicated prevention). However, universal prevention may be more scalable, equitable, and cost-beneficial.
Effectiveness of ROSE for preventing PPD among people at risk is known. To assess ROSE as universal prevention, we need to determine the effectiveness of ROSE among all pregnant people, including those screening negative for PPD risk. We will enroll 2320 pregnant people, assess them with commonly available PPD risk prediction tools, randomize everyone to ROSE or enhanced care as usual, and assess ROSE as universal, selective, and indicated prevention in terms of: (1) effectiveness (PPD prevention and functioning), (2) cost-benefit, (3) equity (PPD cases prevented by universal prevention that would not be prevented under selective/indicated for minority vs. non-Hispanic white people), (4) quantitative and qualitative measures of scalability (from 98 agencies previously implementing ROSE), (5) ROSE mechanisms across risk levels. We will integrate results to outline pros and cons of the three prevention approaches (i.e., universal, selective, indicated).
This will be the first trial to assess universal vs. selective/indicated PPD prevention. Trial design illustrates a novel, efficient way to make these comparisons. This trial, the largest PPD prevention trial to date, will examine scalability, an understudied area of implementation science.
摘要:
目的:为了检查有效性,成本-结果,股本,可扩展性,和伸出手的机制,保持坚强,新生儿母亲的要点(ROSE)产后抑郁症预防(PPD)计划作为普遍与选择性或指示性预防。
背景:美国预防服务工作组(USPSTF)目前建议对有PPD风险的孕妇进行PPD预防(即,选择性/指示预防)。然而,普遍预防可能更具可扩展性,公平,和成本效益。
方法:已知ROSE在高危人群中预防PPD的有效性。为了评估ROSE是普遍的预防措施,我们需要确定ROSE在所有孕妇中的有效性,包括PPD风险筛查阴性。我们将招募2320名孕妇,使用常用的PPD风险预测工具对其进行评估,像往常一样将每个人随机分配到ROSE或加强护理,并评估ROSE是普遍的,选择性,并指出预防方面:(1)有效性(PPD预防和功能),(2)成本效益,(3)公平(普遍预防防止PPD案件,在少数群体与少数群体的选择性/指示下不会防止非西班牙裔白人),(4)可扩展性的定量和定性措施(来自先前实施ROSE的98个机构),(5)跨风险级别的ROSE机制。我们将整合结果,概述三种预防方法的利弊(即,普遍,选择性,指示)。
结论:这将是第一个评估普遍性与选择性/指示性PPD预防。试验设计说明了一个小说,进行这些比较的有效方法。这次审判,迄今为止最大的PPD预防试验,将检查可扩展性,实施科学的一个研究不足的领域。
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